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Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by University of California, Irvine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580697
First Posted: December 27, 2007
Last Update Posted: May 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Irvine
  Purpose
This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.

Condition
Lower Urinary Tract Symptoms Gynecologic Malignancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • The outcome will be measured using validated general and condition-specific questionnaires. [ Time Frame: 7 months ]

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:
Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Have a diagnosis of a gynecologic malignancy: cervical, endometrial, or ovarian cancer, and plan to have surgry for the cancer treatment.
Criteria

Inclusion Criteria:

  • Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer.

Exclusion Criteria:

  • Subjects less than 18 years of age
  • Subjects unable to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580697


Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen L Noblett, M.D. University of California, Irvine
  More Information

Responsible Party: Karen Noblett, Associate Professor, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00580697     History of Changes
Other Study ID Numbers: 2006-4825
First Submitted: December 19, 2007
First Posted: December 27, 2007
Last Update Posted: May 10, 2010
Last Verified: May 2010

Keywords provided by University of California, Irvine:
Lower urinary tract symptoms
Gynecologic malignancy
Urinary incontinence
Fecal incontinence
Frequency
Voiding dysfunction
Sexual dysfunction

Additional relevant MeSH terms:
Neoplasms
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms